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EP3341174B1 - Procédé et appareil de moulage d'article creux allongé - Google Patents

Procédé et appareil de moulage d'article creux allongé

Info

Publication number
EP3341174B1
EP3341174B1 EP16759916.6A EP16759916A EP3341174B1 EP 3341174 B1 EP3341174 B1 EP 3341174B1 EP 16759916 A EP16759916 A EP 16759916A EP 3341174 B1 EP3341174 B1 EP 3341174B1
Authority
EP
European Patent Office
Prior art keywords
mold
end mold
flow rate
cavity
molding
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP16759916.6A
Other languages
German (de)
English (en)
Other versions
EP3341174A1 (fr
Inventor
Horacio Montes De Oca Balderas
Herbert Eichler
Gottfried Steiner
Daniel A. MARCH
Gilberto MARCHETTI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hollister Inc
Original Assignee
Hollister Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hollister Inc filed Critical Hollister Inc
Publication of EP3341174A1 publication Critical patent/EP3341174A1/fr
Application granted granted Critical
Publication of EP3341174B1 publication Critical patent/EP3341174B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/17—Component parts, details or accessories; Auxiliary operations
    • B29C45/1703—Introducing an auxiliary fluid into the mould
    • B29C45/1704—Introducing an auxiliary fluid into the mould the fluid being introduced into the interior of the injected material which is still in a molten state, e.g. for producing hollow articles
    • B29C45/1705—Introducing an auxiliary fluid into the mould the fluid being introduced into the interior of the injected material which is still in a molten state, e.g. for producing hollow articles using movable mould parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/17—Component parts, details or accessories; Auxiliary operations
    • B29C45/1703—Introducing an auxiliary fluid into the mould
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/17—Component parts, details or accessories; Auxiliary operations
    • B29C45/26—Moulds
    • B29C45/261—Moulds having tubular mould cavities
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/17—Component parts, details or accessories; Auxiliary operations
    • B29C45/46—Means for plasticising or homogenising the moulding material or forcing it into the mould
    • B29C45/56—Means for plasticising or homogenising the moulding material or forcing it into the mould using mould parts movable during or after injection, e.g. injection-compression moulding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/17—Component parts, details or accessories; Auxiliary operations
    • B29C45/46—Means for plasticising or homogenising the moulding material or forcing it into the mould
    • B29C45/56—Means for plasticising or homogenising the moulding material or forcing it into the mould using mould parts movable during or after injection, e.g. injection-compression moulding
    • B29C2045/5695—Means for plasticising or homogenising the moulding material or forcing it into the mould using mould parts movable during or after injection, e.g. injection-compression moulding using a movable mould part for continuously increasing the volume of the mould cavity to its final dimension during the whole injection step
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2023/00—Tubular articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7542—Catheters

Definitions

  • the present disclosure relates to a method and apparatus for molding an elongated hollow article, such as a urinary catheter.
  • WO 2014/052770 illustrates a system and method for forming an elongated hollow article having substantially constant diameters of both outer surface and central hole, producing a constant wall thickness, such as a urinary catheter.
  • US 2443053 illustrates a system and method for forming a hollow article having a substantially constant wall thickness, such as a toothpaste tube.
  • injection molding has generally been limited to relatively short tubular lengths in relation to the diameter of the central passage. If, for example, the tubular product is to be relatively long, which is quite common in the medical industry generally and relative to catheters in particular, a small hole, especially a hole in a thin walled tube, is extremely difficult to make with any great degree of accuracy. In addition, different materials provide different problems.
  • Another problem generally associated with the injection molding technique of products of the type referred to above is the breakdown of the plastic material utilized to form the tubular product when the material is forced to travel along what may be referred to as a circuitous path from the point of leaving the injection nozzle to the point of entering and passing along the length of the mold cavity. This is particularly true when the plastic material, after being melted, is forced to flow along a circuitous path or a path including one or more right angles at a relatively high speed. Attempts to slow the speed of injection of the inflowing melt however have met with little success especially in the formation of thin walled tubular products. This is primarily because the melt rapidly cools and therefore solidifies as it flows along the length of the mold cavity especially at slow speeds.
  • the present disclosure relates to a molding apparatus and a molding process embodying advantageous alternatives to existing apparatuses and methods, which may provide for improved molding of elongated hollow articles, such as urinary catheters.
  • This method may be advantageous because this method can be adopted for producing elongated articles, such as urinary catheters, of a variety of lengths, in principle any lengths.
  • This method is particularly advantageous where the elongated hollow article is a catheter with a proximal tip and a distal funnel-shaped connector end.
  • the costs of manufacturing such articles can be reduced since the articles can be produced in a reduced amount of molding processes, preferably a single molding process.
  • the varying step includes balancing the material flow rate, the end mold speed and the fluid flow rate.
  • the varying step includes increasing the material flow rate after the end mold begins moving, and decreasing subsequently the material flow rate before the end mold reaches the second position.
  • the varying step may include increasing the material flow rate immediately after the end mold begins moving, and decreasing subsequently the material flow rate before the end mold reaches the second position.
  • the varying step includes progressively increasing the end mold speed as the end mold moves between the first position and the second position. Moreover, the varying step may include progressively increasing the end mold speed as the end mold moves between the first position and a third position between the first and second positions, and substantially increasing the end mold speed as the end mold moves between the third and second positions.
  • the supplying step may occur simultaneously with the moving step.
  • the supplying step is delayed relative to the moving step.
  • the fluid provided inside the article as a consequence of the supplying step stabilizes the material of the molded portion of the article during the molding process as this portion leaves the inner support of the elongated mold core.
  • the fluid also may help solidify the material and ensure the shape of the article even though the material may not yet be solidified immediately after leaving the elongated mold core.
  • the method may also include the step of cooling the hollow article when the end mold has reached the second position.
  • the cooling may be performed by a set of cooling mold blocks or inserts that are provided for encompassing the molded portion of the article by radially inward movement.
  • the cooling mold blocks may be provided with inner contacting surfaces resembling the shape of the tubular mold cavity.
  • the cooling mold blocks are formed with end contacting surfaces having an end section geometry, and the varying step may include increasing the fluid flow rate immediately before the end mold reaches the second position.
  • a sub-process of blow molding the second end shape of the elongated hollow article is provided. This is particularly advantageous when producing a catheter with a proximal tip and a distal, funnel-shaped connector end.
  • the method may further include cutting the molded article away from the mold by providing a cuter in a gap between the cooling blocks and the outer mold with the end mold at the second position.
  • the molded article is easily freed from the mold to complete the molding cycle.
  • the method may also include controlling the temperature of the outer mold to maintain a temperature at which the molding material is liquidized.
  • embodiments of the method may include controlling the temperature of the elongated central mold core to maintain a temperature similar to that of the outer mold. More particularly, such temperature is above the melting temperature of the molding material, such as between +130°C and +350°C depending on the polymer material used for the molding process.
  • embodiments may control the temperature of the movable end mold to maintain a temperature lower than that of the outer mold. In particular, the temperature of the movable end mold is kept below the melting temperature for the molding material, such as between +20°C and +130°C, which is also well below the glass temperature of the polymer materials used for molding the article.
  • the molding apparatus is configured to balance the material flow rate, the end mold speed and the fluid flow rate as the end mold moves between the first position and the second position.
  • the molding apparatus may be configured to increase the material flow rate after the end mold begins moving, and decrease subsequently the material flow rate before the end mold reaches the second position.
  • the molding apparatus according to certain embodiments is configured to increase the material flow rate immediately after the end mold begins moving, and decrease subsequently the material flow rate before the end mold reaches the second position.
  • the molding apparatus is configured to progressively increase the end mold speed as the end mold moves between the first position and the second position.
  • the molding apparatus may be configured to progressively increase the end mold speed as the end mold moves between the first position and a third position between the first and second positions, and to substantially increase the end mold speed as the end mold moves between the third and second positions.
  • the molding apparatus is configured to increase a fluid flow rate of the fluid via the valve simultaneously as the end mold moves between the first position and the second position.
  • the molding apparatus is configured to increase a fluid flow rate of the fluid via the valve after the end mold begins to move between the first position and the second position.
  • the molding apparatus may be configured to increase the fluid flow rate immediately before the end mold reaches the second position.
  • the molding apparatus is configured to cool the hollow article when the end mold part has reached the second position.
  • the molding apparatus may include a set of cooling mold blocks, and wherein the molding apparatus is configured to move the cooling mold blocks radially inward to encompass the molded portion of the hollow article.
  • the cooling mold blocks may include inner contacting surfaces resembling the shape of the tubular mold cavity and end contacting surfaces having an end section geometry, and the molding apparatus is configured to supply fluid to the core to form said end section geometry.
  • the molding apparatus may include a cuter in a gap between the cooling blocks and the outer mold with the end mold at the second position.
  • Embodiments of the molding apparatus may be configured to control the temperature of the outer mold to maintain a temperature at which the molding material is liquidized. Moreover, the molding apparatus may be configured to control the temperature of the elongated central mold core to maintain a temperature similar to that of the outer mold. Further, the molding apparatus may be configured to control the temperature of the movable end mold to maintain a temperature lower than that of the outer mold.
  • the molding apparatus may include one or more controllers coupled to one or more of the metering device, the actuator and the valve, the one or more controllers configured to control the one or more of the metering device, the actuator and the valve.
  • the one or more controllers may each comprise one or more processors programmed to control the one or more of the metering device, the actuator and the valve.
  • FIGs. 1-12 an embodiment of a molding apparatus and a molding sequence is disclosed.
  • Figs. 1 and 2 illustrate an embodiment of a molding apparatus
  • Figs. 3-12 illustrate, step by step, a molding sequence that may be carried out using the apparatus of Figs. 1 and 2 .
  • the molding apparatus appears to be disposed horizontally in Figs. 1 and 2 , this is for ease of illustration only.
  • the molding apparatus would be disposed more typically in a substantially vertical orientation in use, similar to the orientation illustrated in Figs. 3-12 .
  • the molding apparatus includes a stationary outer mold 1 and a stationary elongated mold core 2, which mold 1 and core 2 define a cavity 3 therebetween.
  • the cavity 3 is tubular in shape.
  • the tubular cavity 3 is cylindrical with an annular cross-section.
  • other cross-sectional shapes may be provided.
  • An inlet 5 may be provided substantially radially to the elongated mold core 2 to receive molding material, such as a thermoplastic elastomer for example.
  • molding material such as a thermoplastic elastomer for example.
  • a supply of molding material 100 may be provided, and may be coupled to the inlet 5 via a metering device 101, which metering device 101 controls the rate at which molding material is provided to the inlet 5.
  • the elongated mold core 2 is provided with an end section so that the extent of the cavity 3 is limited at the inlet 5 but extends beyond the outer mold 1 and into an end mold 30 (as best seen in Fig. 4 , for example). In the end mold 30, there is provided an end cavity 12.
  • the end cavity 12 of the end mold 30 may be formed to define the tip of the catheter.
  • the end cavity 12 may have a rounded shape that defines the catheter tip, such a Nelaton tip, and the core 2 may have a similar shape to match. See Figs. 3-13 .
  • the end mold 30 may also be referred to as a tip mold, and the end cavity 12 as a tip end cavity.
  • the end cavity 12 of the end mold 30 may be formed to define the funnel-shaped connector end.
  • the end cavity may have a tubular shape (e.g., cylindrical with an annular cross-section), with an inner taper. See Figs. 18-21 .
  • the end mold 30 is in its initial position positioned adjacent the outer mold 1 so that the tubular cavity 3 and the end cavity 12 are aligned and the end of the elongated mold core 2 extends into the end cavity 12.
  • the outer mold 1 and the elongated mold core 2 maintained at an elevated temperature by providing a heater 7 therein, which heater 7 may be in the form of an electrical or (heated) fluid circuit, for example.
  • the stationary mold members, i.e., the outer mold 1, the elongated mold core 2 and the inlet 5, are thereby maintained at a temperature above the melting temperature of the molding material, e.g. +175°C for polyvinylchloride (PVC) or in the range of +160°C to +350 °C for other polymer materials.
  • PVC polyvinylchloride
  • the cavity 3 is filled with molding material 20 in accordance with a conventional injection molding process (see Figs. 4 and 5 ).
  • the end mold 30 starts moving in the direction D 3 , as shown in Fig. 6 .
  • the end mold 30 may be coupled (i.e., directly or indirectly attached or connected to) an actuator 103 that may be controlled to move the end mold 30 relative to the outer mold 1 and the elongated mold core 2.
  • the actuator 103 may be a linear actuator, for example.
  • pressurized fluid may be supplied from a pressurized fluid source 104 (see Fig. 1 ) through a central axial fluid channel 9 in the elongated mold core 2 and into the internal volume 9b of the molded portion 20a of the product (see Fig. 6 ).
  • the pressurized fluid is provided inside the article during the molding to assist in forming the inner surface of the hollow article and avoid the formation of a vacuum inside the hollow portion 9b of the article.
  • the pressurized fluid is air. It will be recognized that the fluid channel 9 can be used for fluids other than air, such as a gas composition, a liquid mixture, a reactive liquid mixture, etc.
  • the end mold 30 is kept cool, e.g. at +40°C for PVC (and +20 °C to +130 °C for other polymers), i.e. well below the melting temperature of the polymer molding material 20.
  • the molding material 20 is in a liquidized state in the heated section of the mold but is cooled and thereby solidifies as it leaves the heated mold members.
  • the pressurized air supplied to the inside of the product formed stabilizes the molded portion 20a of the tubular product that is in the process of being molded.
  • the molded portion 20a is thereby prevented from collapsing as it is pushed off the elongated mold core 2 by the liquidized molding material 20, which is continuously being supplied under a predetermined pressure through the inlet 5.
  • This pushing of the molded product is also assisted by the supply of pressurized air through the fluid channel 9 and into the inner volume 9b of the molded portion 20a as well as the movement of the end mold 30, which also assists the advancement of the molded portion 20a off the elongated mold core 2.
  • the end mold 30 is arranged on a sledge 34 arranged for a linear movement in the direction D 3 .
  • a set of cooling mold blocks 32, 33 are provided around the tubular molded portion 20a to cool the product, as shown in Fig. 8 .
  • the mold blocks 32, 33 may be moved around the tubular molded portion 20a using one or more actuators 106 coupled (i.e., connected or attached directly or indirectly) to the mold blocks 32, 33.
  • the cooling mold blocks 32, 33 may include a cooling system 8 (e.g., a coolant circuit including one or more passages for the movement of a coolant, such as water).
  • the mold blocks 32, 33 may be used to add a predetermined pattern on the catheter surface.
  • the inner surfaces of the mold blocks 32, 33 may be machined or fabricated such that when the tubular molded portion 20a is brought into contact with the inner surfaces of the mold blocks 32, 33 (for example, by selecting a particular size for the inner diameter of the cavity defined by the mold blocks 32, 33 or by increasing the air flow through the fluid channel 9), the catheter surface acquires a pattern.
  • This pattern on the catheter surface can facilitate application of wetting agents and coating layers that are typically used to improve lubricity of catheters and facilitate insertion into the human body.
  • the molding cycle is coming toward an end and the cooling blocks 32, 33 follow the movement of the tubular product 20a and create a gap 35 between the cooling blocks 32, 33 and the mold 1.
  • This cooling method is particularly suitable for materials sensitive to conventional cooling fluids, like water, oil, etc.
  • a water bath can also be used to cool and solidify the part if needed.
  • a cutter 31 may be provided in the gap 35, as illustrated in Fig. 10 .
  • This cutter 31 preferably includes a set of knifes which guillotines the tubular product and thereby cuts away the molded product 20a from the hot mold.
  • the cutter 31 may preferably be provided with cooling system 8 (e.g., a coolant circuit including one or more passages for the movement of a coolant, such as water) so that the product is cooled when the cutter 31 is moved into its active position.
  • the cutter 31 may be provided with one or more actuators 107 that move the cutter 31 (e.g., the set of knives) to cut the molded product from the hot mold.
  • the cutter 31 is removed and the end mold 30 is then moved further whereby the product 20a is held between the two cooling mold blocks 32, 33, as shown in Fig. 11 .
  • the product is thereafter freed as shown in Fig. 12 , and the molding cycle may repeat by returning to the stage illustrate in Fig. 4 , where the end mold 30 is returned to its initial position abutting the outer mold 1 disposed about or around the elongated mold core 2.
  • the cooling mold blocks 32, 33 may be formed with a funnel cavity 40 at the mold facing end (see Fig. 13 ) so that when the mold blocks 32, 33 are clamped around the tubular molded product as shown in Fig. 9 , the pressurized air being supplied from the fluid passage 9 of the elongated mold core 2 may be utilized to blow molding a funnel shape or another predetermined end geometry in the product prior to the cutting action at the stage illustrated in Fig. 10 .
  • the predetermined geometry of the hollow article may also comprise an oval shape at specific sections of the tube, or a structured outer surface pattern of the tube or parts of the tube, such as a honeycomb pattern or the like.
  • a catheter may be produced with a straight tube 15 cm long from the molded tip, followed by a gradual inner and outer diameter increase over the next 5 cm, followed by a straight tube with a larger inner and outer diameter (when compared with the first straight tube section) for the last 20 cm of a 40 cm long catheter.
  • a general molding process 200 to manufacture a catheter using a stationary outer mold 1, a stationary elongated mold core 2 and a moveable end mold 30 is illustrated in Fig. 14 .
  • the process may be varied to produce catheters of different shapes and sizes.
  • a limited number of specific variants to the process 200 are illustrated in Figs. 15-17 . It will be recognized, however, that the process 200 envisions other variations in the process parameters as well, and a balancing of parameters may occur as part of the process 200 as is explained below.
  • Description of the process 200 begins at block 202 in Fig. 14 with the end mold 30 in its initial position adjacent the outer mold 1 so that the tubular cavity 3 and the end cavity 12 are aligned and the end of the elongated mold core 2 extends into the end cavity 12. See Figs. 4 and 5 .
  • the process 200 then passes to block 204 with molding material being injected into the cavity 3, including the end cavity 12.
  • motion of the end mold 30 relative to the outer mold 1 and the elongated mold core 2 is initiated at block 206, and flow of the fluid to the elongated mold core 2 is initiated at block 208.
  • the process 200 then continues at block 210, wherein the speed of the end mold, the flow rate of the molding material and/or the flow rate of fluid to the mold core 2 may be varied.
  • the speed of the end mold may be progressively increased as the length of the catheter is increased, while the flow rate of the molding material may be initially increased once movement of the end mold is initiated, before the flow rate is decreased to an approximately constant flow rate.
  • the flow of fluid e.g., air
  • the changes in speed and flow rate of molding material may be performed in a series of discrete, stepwise changes, or the changes in speed and flow rate may vary in a continuous fashion from a starting value to an ending value.
  • the end mold is stopped, and the flow of molding material and fluid to the core 2 is halted at block 212.
  • cooling inserts may be advanced into contact with the catheter at block 214.
  • a delay (block 207) is introduced between the initiation of the motion of the end mold and the initiation of the fluid flow to the mold core 2. See also Example 2, below.
  • the result of such a process may be a catheter with a rounded tip and a region of reduced inner and outer diameter immediately adjacent the tip. As illustrated in Fig.
  • a sudden increase in the speed of the end mold 30 may occur at block 211 prior to stopping the end mold, molding material flow and fluid flow at block 212. See also Example 3, below.
  • the result of such a process also may be a catheter with a rounded tip and a region of reduced inner and outer diameter immediately adjacent the tip.
  • a sudden increase in the fluid flow rate at block 215 after applying the cooling inserts at block 214 may cause the catheter diameter at the distal end to increase, such that a funnel shape may be formed at the distal end of the catheter in accordance with a catheter formed on the inner surface of the cooling inserts. See Example 4, below.
  • the process 200 at blocks 206, 208 and 210 involves a balance between different parameters as they affect the motion of the catheter exiting the core 1.
  • the motion of the extruding catheter using cylindrical coordinates (from Tadmor & Gogos, Principles of Polymer Processing, 111 (John Wiley & Sons ):
  • the velocity of the fluid around the vertical direction ( v ⁇ ) may be assumed to be zero. That is, while it is possible to rotate the end mold 30 to cause the velocity v ⁇ to be non-zero, for purposes of the balance described herein, it will be assumed that the end mold 30 is not rotated. Because the velocity around the vertical direction is assumed to be zero, the second equation becomes zero, and the first and third equations are the equations of interest.
  • the right-hand side of the first and third equations include terms relating to the speed of the material in the radial and vertical directions, as well as partial differentials of the speed in the radial and vertical directions with respect to time and with respect to the radial and vertical directions.
  • the structure and operation of the molding apparatus according to embodiments of the present disclosure permits the pressure gradient ⁇ P/ ⁇ z to vary, reflected in a variation in the flow rate of molding material passing through the mold.
  • the molding apparatus according to embodiments of the present disclosure permits the pressure gradient ⁇ P/ ⁇ r to vary, reflected in a variation in the force directed outwardly against the wall of the molded product 20a.
  • the viscosity terms are dependent upon the material in question.
  • they represent a constitutive relation in that they are dependent upon the external forces applied to the material, such as the pressure gradients for the molded material and the fluid (air) exiting the core 2, gravity, and the downward force applied to the tubular section of the molded product 20a via the end mold 30.
  • the process 200 thus represents a balance between pressure/flow rate, speed and the constitutive relations. For example, it the pressure gradients ⁇ P/ ⁇ z and ⁇ P/ ⁇ r are equal to zero (related to a constant flow rate and a constant fluid pressure), then a molded product 20a with constant inner and outer diameters may be produced by maintaining a constant speed for the end mold 30. On the other hand, if the pressure gradients are equal to zero and the end mold 30 is accelerated away from the outer mold 2/mold core 2, a tapered tube is produced.
  • the process 200 may include heating the outer mold 1 and the mold core 2 throughout the process, as explained above.
  • the process 200 may include coupling a vacuum pump to the cavity 3 after the mold is disposed in its initial position at block 202 before injecting molding material into the cavity 3 at block 204.
  • the pump is activated to remove air from the cavity 3 and facilitate polymer flow into the cavity, and once a desired vacuum is developed (e.g., 20% atmospheric pressure) the molding material is injected.
  • a desired vacuum e.g. 20% atmospheric pressure
  • the valve 105 would be closed to decouple the fluid (air) source 104 from the cavity 3.
  • controllers 108 may be provided, as illustrated in Fig. 1 .
  • the controller(s) 108 may be coupled (via couplings A, B, C, D, and E) to the metering device 101, the actuators 103, 106, 107, and/or the valve 105 to control the metering device 101, the actuators 103, 106, 107 and/or the valve 105 according to the process 200 described above.
  • the controller(s) 108 may vary the rate at which molding material is provided to the inlet 5 by varying the operation of the metering device 101, the speed of the end mold 30 by varying the operation of the actuator 103, and the rate of fluid supplied to the core 8 by varying the operation of the valve 105. While the controller(s) 108 is illustrated as coupled directly to the metering device 101, the actuators 103, 106, 107, and the valve 105, additional equipment (e.g., drives) may be disposed between the controller(s) 108 and the metering device 101, actuator 103, and/or valve 105.
  • additional equipment e.g., drives
  • the controller(s) 108 may include electrical circuit components and/or one or more uniquely programmed processors.
  • the instructions by which the processor is programmed may be stored on a memory associated with the processor.
  • the memory may include one or more tangible non-transitory computer readable memories, having computer executable instructions stored thereon, which when executed by the processor, may cause the one or more processors to carry out one or more actions.
  • the controller(s) 108 may be programmed to control one or more of the metering device 101, the actuator(s) 103, 106, 107 and the valve 105, such as to carry out a process according to any of the embodiments discussed herein for example.
  • the molding apparatus included a one-piece end mold capable of producing a Nelaton tip, mounted on a sledge movable in the vertical direction.
  • the sledge was coupled to a controller capable of starting and stopping the sledge, as well as controlling the speed of the sledge at different stages of the process.
  • the machine also included an elongated core connected to an air source via an air valve.
  • the air valve was coupled to an air flow meter capable of opening and closing the air valve, as well as controlling the airflow rate at different stages of the process.
  • the machine also included cooling inserts movable about the catheter once the sledge reached a specific position.
  • the inserts were attached to actuators coupled to a controller capable of starting and stopping the actuators so that the cooling inserts were moved between a first position where the inserts were spaced from the catheter and a second position where the inserts were about the catheter.
  • the molding material used was Teknorapex Medalist MD585 thermoplastic elastomer (TPE) resin, at a temperature of 170 °C and a pressure not exceeding 550 bar.
  • TPE thermoplastic elastomer
  • the bending stiffness was used as a characteristic of the catheters for comparison purposes.
  • the bending stiffness of the catheter was obtained from force versus displacement curves measured in duplicate at room temperature with an Instron 5543 tensile testing apparatus operated a 4.27 mm/min, a 10N load cell, and the 3-point bending configuration with the load applied at the midpoint between two supports separated 7.5 cm apart.
  • a pre-load of 0.02N was applied to the midpoint, and the pre-load was zeroed prior to collecting the force versus displacement curve data.
  • the bending stiffness was obtained from the secant point at 2 mm displacement and the origin of the curve.
  • a straight catheter tube 40cm long was produced with the following process parameters: Position # 1 2 3 4 5 6 7 8 9 10 Mold end position from die [mm] 0 9 67 117 167 257 287 287 389 400 Polymer flow rate [cm 3 /s] 2.2 2.2 3.0 0.8 0.8 0.8 0.8 0.8 0 Sledge speed [mm/s] 0 25 25 30 35 35 35 40 40 0 Air flow [L/min] 0 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6
  • the bending stiffness was measured at different positions along the length of the catheter and the results are shown below: Distance from the catheter tip [mm] 50 150 250 350 Bending stiffness [N/mm] 0.15 ⁇ 0.02 0.15 ⁇ 0.02 0.15 ⁇ 0.02 0.15 ⁇ 0.02 0.15 ⁇ 0.02 Outer diameter [mm] 5.6 ⁇ 0.2 5.6 ⁇ 0.2 5.6 ⁇ 0.2 5.6 ⁇ 0.2 Inner diameter [mm] 5.0 ⁇ 0.1 5.0 ⁇ 0.1 5.0 ⁇ 0.1 5.0 ⁇ 0.1 5.0 ⁇ 0.1 ⁇ 0.1
  • the variations in tip mold/sledge speed, polymer flow rate, and airflow rate produced a catheter having a uniform (constant) inner and outer diameter, and a uniform (constant) bending stiffness.
  • a straight catheter tube 40cm long with a narrow tip was produced with the following process parameters: Position # 1 2 3 4 5 6 7 8 9 10 Mold end position from die [mm] 0 3 9 117 167 257 287 287 389 400 Polymer flow rate [cm 3 /s] 2.2 2.2 3.0 0.8 0.8 0.8 0.8 0.8 0 Sledge speed [mm/s] 0 25 25 30 35 35 35 40 40 0 Air flow [L/min] 0 0.0 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6
  • the variations in end mold/sledge speed, polymer flow rate, and air flow rate produced a catheter having a uniform (constant) inner and outer diameter and a uniform (constant) bending stiffness outside a region adjacent the tip. Inside the region, the inner and outer diameters were significantly smaller that outside the region and the stiffness was too small to measure using the equipment and process described above.
  • a variable stiffness partially tapered catheter tube 40cm was produced with the process parameters shown in the table below.
  • the process described above produced a catheter with an increasing inner diameter, outer diameter and bending stiffness (as measured from the catheter tip). Moreover, the structure produced does not have a constant taper angle along the catheter length. The taper angle changes along the catheter length, showing a sudden increase or transition in the region between 50 and 150 mm from the tip. Thereafter, the taper angle increases slowly. The taper almost disappears at the end opposite the tip, where the tube almost straight.
  • a straight catheter tube 40cm long with a blow molded funnel portion was produced with the following process parameters: Position # 1 2 3 4 5 6 7 8 9 10 Mold end position from die [mm] 0 9 67 117 167 257 287 287 389 400 Polymer flow rate [cm 3 /s] 2.2 2.2 3.0 0.8 0.8 0.8 0.8 0.8 0 Sledge speed [mm/s] 0 25 25 30 35 35 35 40 40 0 Air flow [L/min] 0 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.6 25
  • the bending stiffness was measured at different positions along the length of the catheter and the results are shown below: Distance from the catheter tip [mm] 50 150 250 350 Bending stiffness [N/mm] 0.15 ⁇ 0.02 0.15 ⁇ 0.02 0.15 ⁇ 0.02 0.15 ⁇ 0.02 0.15 ⁇ 0.02 Outer diameter [mm] 5.6 ⁇ 0.2 5.6 ⁇ 0.2 5.6 ⁇ 0.2 5.6 ⁇ 0.2 Inner diameter [mm] 5.0 ⁇ 0.1 5.0 ⁇ 0.1 5.0 ⁇ 0.1 5.0 ⁇ 0.1 5.0 ⁇ 0.1 ⁇ 0.1
  • the cooling mold blocks according to this example had an end section geometry that defined a funnel shape.
  • the increase in the fluid flow rate at the final step of the process caused the molded article to be forced outwardly into contact with the end section geometry, producing a catheter with a proximal tip and a distal, funnel-shaped connecter end thereby.
  • Figs. 18 and 19 illustrate an embodiment wherein the end mold 30 is used to form the connector end of a catheter, instead of the tip of the catheter.
  • the molding apparatus includes a stationary outer mold 1 and a stationary elongated mold core 2, which mold 1 and core 2 define a tubular cavity 3 therebetween.
  • An inlet 5 may be provided to receive molding material 20, such as a thermoplastic elastomer for example.
  • the elongated mold core 2 is provided with an end section so that the extent of the cavity 3 is limited at the inlet 5 but extends beyond the outer mold 1 and into an end mold 30, and in particular an end cavity 42.
  • the tubular cavity 3 and the end cavity 42 are aligned and the end of the elongated mold core 2 may extend slightly into the end cavity 42.
  • the end mold 30 starts moving.
  • the filling of the end cavity 42 in this context does not necessarily require the filing of the complete end cavity 42: according to certain embodiments, the end cavity may be partially filled or filled with a pre-formed or pre-molded connector end (or funnel) prior to the step of injecting molding material into the cavities 3, 42 so as to overmold the pre-molded part.
  • pressurized fluid may be supplied from a pressurized fluid source through a central axial fluid channel 9 in the elongated mold core 2 and into the internal volume 9b of the molded portion 20a of the product (see Fig. 19 ).
  • the end mold 30 is kept cool, i.e. well below the melting temperature of the polymer molding material 20.
  • the pressurized air supplied to the inside of the product formed stabilizes the molded portion 20a of the tubular product that is in the process of being molded.
  • a set of cooling mold blocks 43, 44 are provided around the tubular molded portion 20a to cool the product.
  • the cooling mold blocks 43, 44 may include a cooling system 8 (e.g., a coolant circuit including one or more passages for the movement of a coolant, such as water).
  • the mold blocks 43, 44 may be used to add a predetermined pattern on the catheter surface. Further, the mold blocks 43, 44 may have a surface that defines the tip end of the catheter 20a with the cooling blocks 43, 44 clamped around the molded product 20, as shown in Fig. 19 .
  • a funnel portion (connector end) of a catheter may be followed by extrusion of a tubular portion, with the catheter tip being formed using cooling blocks or inserts.
  • a pre-formed or pre-molded funnel may be mounted or disposed within the end mold and a tube portion may be overmolded onto the pre-molded funnel, again with the catheter tip being formed using the cooling blocks or inserts.
  • Figs. 20 and 21 illustrate an embodiment wherein a valve is included to prevent the (back)flow of molding material into the axial fluid channel, thereby limiting the number of articles that may be produced. While the embodiment of Figs. 20 and 21 includes an end mold 30 that may be used to form the connector end (or funnel) of a catheter, as opposed to the tip of the catheter, there is nothing herein that limits the embodiment as such. In fact, the embodiment of Figs. 20 and 21 may be used in conjunction with the mold and mold core that are used to form a tip, such as are illustrated in Figs. 1-13 , as well.
  • the molding apparatus includes a stationary outer mold 1 and a stationary elongated mold core 2, which mold 1 and core 2 define a tubular cavity 3 therebetween.
  • An inlet 5 may be provided to receive molding material, such as a thermoplastic elastomer for example.
  • the elongated mold core 2 is provided with an end section so that the extent of the cavity 3 is limited at the inlet 5 but extends beyond the outer mold 1 and into an end mold 30, and in particular an end cavity 42.
  • the tubular cavity 3 and the end cavity 42 are aligned and the end of the elongated mold core 2 may extend slightly into the end cavity 42.
  • the end mold 30 starts moving.
  • pressurized fluid may be supplied from a pressurized fluid source through a central axial fluid channel 9 in the elongated mold core 2 and into the internal volume 9b of the molded portion 20a of the product (see Fig. 21 ).
  • molding material 20 may move into the fluid channel 9 (or backflow) either before or as the end mold 30 begins to move relative to the stationary mold 1 and mold core 2. It is believed that the molding material 20 may have a tendency to enter the fluid channel 9 as a consequence of the pressure applied to the molding material 20 to make the molding material to move through the cavity 3 and into the end cavity 42.
  • the entry of the molding material 20 into the fluid channel 9 may cause the fluid channel 9 to become obstructed, which obstruction may limit or even prevent the flow of fluid through the fluid channel 9 into the internal volume 9b of the molded portion 20a of the product. If this occurs, then it may be necessary to interrupt production of the product to remove the obstruction from the fluid channel 9.
  • the obstruction thus may have consequences not only on the number of individual instances of the product that may be made between such interruptions, but may influence the smooth operation of downstream manufacturing, assembly and packaging process as well as the cost of the product (because the need for frequent servicing of the manufacturing equipment).
  • a valve may be disposed in the fluid channel 9 to prevent the movement of material from the cavities 3, 42 and into the fluid channel 9.
  • the valve includes a mandrel 50 that may define the valve stem, head and face.
  • the mandrel 50 is disposed in the fluid channel 9 so as to be moveable relative to the fluid channel 9, which defines the valve seat.
  • the fluid channel 9 has a longitudinal axis 51 and the mandrel 50 has a longitudinal axis 52, with the longitudinal axis 51 collinear with the longitudinal axis 52.
  • the two axes 51, 52 need not be collinear.
  • the mandrel 50 may have a tapered section 53 disposed at an end 54 of the mandrel 50.
  • the fluid channel 9 may have a tapered inner surface 54, the tapered inner surface 54 cooperating with the tapered section 53 (and in particular the surface of the tapered section 53).
  • the surface of the tapered section 53 and the tapered inner surface 54 may abut to form a seal between the mandrel and the fluid channel 9. This seal may not be entirely fluid-tight, but may present a significant obstacle to the movement of molding material 20 into the fluid channel 9.
  • the mandrel 50 may simply be received with the opening in the end of the fluid channel 9 to limit the movement (backflow) of molding material 20 into the fluid channel 9; according to such an embodiment, the mandrel 50 may extend through and out of the opening to further ensure a seal with the opening.
  • Fig. 20 illustrates the mandrel 50 in a first stage, state or position, wherein the mandrel 20 is received within the fluid channel 9 to limit movement of molding material 20 into the fluid channel 9. This may be referred to as the closed stage, state or position.
  • Fig. 21 illustrates the mandrel 50 in a second stage, state or position, wherein the mandrel 20 is withdrawn along the longitudinal axis 52 so that fluid may move along the fluid channel 9 and out of the opening in the core 2. This may be referred to as the open stage, state or position.
  • the movement of the mandrel 50 may be synchronized with the movement of the end mold 30 and the operation of the fluid source 104. That is, the mandrel 50 will be retained in its closed state (or fully closed state) at least until the end mold 30 begins to move.
  • the movement of the mandrel 50 from its closed state (or fully closed state) to an open state (or fully open state) may be delayed, as explained above, until the end mold 30 has moved or traveled a particular distance from the mold 1 and core 2.
  • the movement of the mandrel 50 from its closed state (or fully closed state) to an open state (or fully open state) may occur simultaneously (or substantially simultaneously) with the movement of the end mold 30.
  • the mandrel 50 may operate as the valve 105 discussed above, or the mandrel 50 (and the valve defined thereby) may function in conjunction with a separate structure that defines the valve 105.
  • the mandrel 50 may limit the movement of the pressurized molding material into the fluid channel 9. As discussed above, the mandrel 50 may extend through the opening in the core 2 at the end of the fluid channel 9 to limit movement of molding material through the opening. In addition, based on the structure of the mandrel 50, the fluid channel 9 and the opening in the core 2, the mandrel 50 (or more generally, the valve defined by the mandrel 50) may prevent movement of the pressurized molding material into the fluid channel 9 and (optionally) the opening in the core 2.
  • the formation of an obstruction within the fluid channel 9 may be limited, or even prevented. This can decrease the number of interruptions required to remove material from the fluid channel 9, and thus increase the number of individual instances of the product (e.g., catheter) that are produced between maintenance sessions and decrease the cost of maintenance and the product.
  • the product e.g., catheter

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  • Engineering & Computer Science (AREA)
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Claims (15)

  1. Procédé de moulage par injection d'un article creux allongé, ledit procédé comprenant les étapes de :
    injection d'un matériau de moulage (20) à un débit de matériau dans un moule comprenant un moule extérieur stationnaire (1) avec une cavité de moule sensiblement tubulaire (3), un moule d'extrémité mobile (30) avec une cavité de moule d'extrémité (12) alignée avec la cavité de moule tubulaire (3), et un noyau de moule allongé stationnaire (2) avec un canal de fluide (9) à travers celui-ci, le noyau de moule (2) se prolongeant à travers la cavité tubulaire (3) dans la cavité de moule d'extrémité (12) ;
    déplacement du moule d'extrémité (30) à une certaine vitesse dans une direction linéaire (D3) d'une première position, avec la cavité de moule d'extrémité (12) alignée avec la cavité de moule centrale (3), vers une deuxième position à une distance prédéterminée entre le moule d'extrémité (30) et le moule extérieur (1) ;
    alimentation du canal de fluide (9) dans le noyau de moule allongé (2) en fluide, à un débit de fluide ; et
    variation, par l'intermédiaire d'un ou plusieurs dispositifs de commande (108), d'au moins l'un du débit de matériau, de la vitesse de moule d'extrémité et du débit de fluide en un ou plusieurs points à mesure que le moule d'extrémité (30) se déplace entre la première position et la deuxième position,
    les un ou plusieurs dispositifs de commande (108) étant configurés pour commander un ou plusieurs d'un dispositif de dosage de matériau de moulage (101) configuré pour injecter le matériau de moulage, d'un actionneur (103) configuré pour déplacer le moule d'extrémité (30) et d'une soupape (105) configurée pour fournir le fluide afin de faire varier l'au moins un du débit de matériau, de la vitesse de moule d'extrémité et du débit de fluide au niveau des un ou plusieurs points à mesure que le moule d'extrémité se déplace entre la première position et la deuxième position.
  2. Procédé selon la revendication 1, dans lequel l'étape de variation comprend l'équilibrage du débit de matériau, de la vitesse de moule d'extrémité et du débit de fluide.
  3. Procédé selon la revendication 1, dans lequel l'étape de variation comprend l'augmentation du débit de matériau après que le moule d'extrémité (30) commence à se déplacer, et la diminution ultérieure du débit de matériau avant que le moule d'extrémité (30) n'atteigne la deuxième position.
  4. Procédé selon la revendication 3, dans lequel l'étape de variation comprend l'augmentation du débit de matériau immédiatement après que le moule d'extrémité (30) commence à se déplacer, et la diminution ultérieure du débit de matériau avant que le moule d'extrémité (30) n'atteigne la deuxième position.
  5. Procédé selon la revendication 1, dans lequel l'étape de variation comprend l'augmentation progressive de la vitesse de moule d'extrémité à mesure que le moule d'extrémité (30) se déplace entre la première position et la deuxième position.
  6. Procédé selon la revendication 5, dans lequel l'étape de variation comprend l'augmentation progressive de la vitesse de moule d'extrémité à mesure que le moule d'extrémité (30) se déplace entre la première position et une troisième position entre les première et deuxième positions, et l'augmentation substantielle de la vitesse de moule d'extrémité à mesure que le moule d'extrémité (30) se déplace entre les troisième et deuxième positions.
  7. Procédé selon la revendication 1, dans lequel l'étape d'alimentation se produit simultanément à l'étape de déplacement.
  8. Procédé selon la revendication 1, dans lequel l'étape d'alimentation est retardée par rapport à l'étape de déplacement.
  9. Procédé selon la revendication 1, dans lequel l'étape de variation comprend l'augmentation du débit de fluide immédiatement avant que le moule d'extrémité (30) n'atteigne la deuxième position.
  10. Procédé selon la revendication 1, comprenant également l'étape de refroidissement de l'article creux lorsque la pièce de moule d'extrémité (30) a atteint la deuxième position.
  11. Procédé selon la revendication 10, moyennant quoi le refroidissement est effectué par un ensemble de blocs de moule de refroidissement (32, 33) qui sont prévus pour englober la partie moulée de l'article par un mouvement radial vers l'intérieur.
  12. Procédé selon la revendication 11, dans lequel les blocs de moule de refroidissement (32, 33) sont dotés de surfaces de contact internes ressemblant à la forme de la cavité de moule tubulaire (3) et dans lequel les blocs de moulage de refroidissement (32, 33) sont formés avec des surfaces de contact d'extrémité (40) ayant une géométrie de section d'extrémité et de l'air sous pression est fourni pour former ladite géométrie de section d'extrémité.
  13. Procédé selon l'une quelconque des revendications précédentes, comportant la régulation de la température du moule extérieur (1) pour maintenir une température à laquelle le matériau de moulage (20) est liquéfié.
  14. Procédé selon la revendication 13, comportant la régulation de la température du noyau de moule central allongé (2) pour maintenir une température similaire à celle du moule extérieur (1) et la régulation de la température du moule d'extrémité mobile (30) pour maintenir une température inférieure à celle du moule extérieur (1).
  15. Appareil de moulage pour un article creux allongé, l'appareil comprenant
    un moule comprenant un moule extérieur stationnaire (1) avec une cavité sensiblement tubulaire (3) formée à l'intérieur de celui-ci, un moule d'extrémité mobile (30) avec une cavité de moule d'extrémité (12) pouvant être alignée avec la cavité de moule tubulaire (3), et un noyau de moule allongé stationnaire (2) avec un canal de fluide (9) à travers celui-ci, le noyau de moule (2) se prolongeant à travers la cavité tubulaire (3) dans une cavité de moule d'extrémité (12) d'une pièce de moule d'extrémité (30) ;
    un dispositif de dosage de matériau de moulage (101) couplé à la cavité sensiblement tubulaire (3) pour commander l'alimentation de la cavité sensiblement tubulaire (3) en matériau de moulage (20) ;
    un actionneur (103) couplé au moule d'extrémité (30) pour déplacer le moule d'extrémité (30) d'une première position, avec la cavité de moule d'extrémité (12) alignée avec la cavité de moule centrale (3), vers une deuxième position à une distance prédéterminée entre le moule d'extrémité (30) et le moule extérieur (1) ; et
    une soupape (105) couplée au canal de fluide (9) pour commander l'alimentation du canal de fluide (9) en fluide,
    dans lequel l'appareil de moulage comprend un ou plusieurs dispositifs de commande (108) configurés pour commander un ou plusieurs du dispositif de dosage (101), de l'actionneur (103) et de la soupape (105) afin de faire varier au moins l'un d'un débit de matériau du matériau de moulage (20) par l'intermédiaire du dispositif de dosage (101), d'une vitesse du moule d'extrémité (30) par l'intermédiaire de l'actionneur (103) et d'un débit de fluide du fluide par l'intermédiaire de la soupape (105) à un ou plusieurs points à mesure que le moule d'extrémité (30) se déplace entre la première position et la deuxième position.
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EP3341174A1 (fr) 2018-07-04
WO2017039992A1 (fr) 2017-03-09
US20210023755A1 (en) 2021-01-28
US20180229412A1 (en) 2018-08-16
DK3341174T3 (da) 2025-11-24
US11701807B2 (en) 2023-07-18
US10875224B2 (en) 2020-12-29

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